Purified Cortrophin Gel

PURIFIED CORTROPHIN GEL- corticotropin injection
ANI Pharmaceuticals, Inc.

DESCRIPTION

Purified Cortrophin Gel is a porcine derived purified corticotropin (ACTH) in a sterile solution of gelatin. It is made up of a complex mixture of ACTH, ACTH related peptides and other porcine pituitary derived peptides.

The drug product is a sterile preparation containing 80 USP units per mL and it contains 0.5% phenol (as preservative), 15.0% gelatin (for prolonged activity), water for injection, and the pH is adjusted with hydrochloric acid and sodium hydroxide.

Purified Cortrophin Gel contains the porcine derived ACTH (1-39) with the following amino acid sequence:

Structure
(click image for full-size original)

CLINICAL PHARMACOLOGY

Purified Cortrophin Gel is the anterior pituitary hormone which stimulates the functioning adrenal cortex to produce and secrete adrenocortical hormones.

Following administration of a single intramuscular injection of 80 Units of Cortrophin gel to healthy volunteers (n=20) in an open label pharmacodynamic study, the median time (range) to reach peak cortisol concentration was 8 (3-12) hours. The baseline corrected geometric mean maximum (CV%) cortisol levels were 34.52 µg/dL (28.2%).

INDICATIONS AND USAGE

Purified Cortrophin Gel is indicated in the following disorders:

1. Rheumatic disorders:

As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:
Psoriatic arthritis.
Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy).
Ankylosing spondylitis.
Acute gouty arthritis.

2. Collagen diseases:

During an exacerbation or as maintenance therapy in selected cases of:
Systemic lupus erythematosus.
Systemic dermatomyositis (polymyositis).

3. Dermatologic diseases:

Severe erythema multiforme (Stevens-Johnson syndrome).
Severe psoriasis.

4. Allergic states:

Atopic dermatitis
Serum sickness.

5. Ophthalmic diseases:

Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:
Allergic conjunctivitis.
Keratitis.
Iritis and iridocyclitis.
Diffuse posterior uveitis and choroiditis.
Optic neuritis.
Chorioretinitis.
Anterior segment inflammation.

6. Respiratory diseases:

Symptomatic sarcoidosis.

7. Edematous states:

To induce a diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus.

8. Nervous system:

Acute exacerbations of multiple sclerosis.

CONTRAINDICATIONS

Purified Cortrophin Gel is contraindicated for intravenous administration.

Purified Cortrophin Gel is contraindicated in patients with scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, hypertension, or sensitivity to proteins derived from porcine sources.

Purified Cortrophin Gel is contraindicated in patients with primary adrenocortical insufficiency or adrenocortical hyperfunction.

WARNINGS

Chronic administration of corticotropin may lead to adverse effects which are not reversible.

This product should not be administered for treatment until adrenal responsiveness has been verified with the route of administration which will be utilized during treatment, intramuscularly or subcutaneously. A rise in urinary and plasma corticosteroid values provides direct evidence of a stimulatory effect. Although the action of corticotropin is similar to that of exogenous adrenocortical steroids the quantity of adrenocorticoid may be variable. In patients who receive prolonged corticotropin therapy the additional use of rapidly acting corticosteroids before, during and after an unusual stressful situation is indicated.

Masking Symptoms of Other Diseases

Corticotropin may only suppress symptoms and signs of chronic disease without altering the natural course of the disease.

Immunogenicity Potential

Purified Cortrophin Gel is immunogenic. Limited available data suggest that a patient may develop antibodies to Purified Cortrophin Gel after chronic administration and loss of endogenous ACTH and Purified Cortrophin Gel activity. Prolonged administration of Purified Cortrophin Gel may increase the risk of hypersensitivity reactions. Sensitivity to porcine protein should be considered before starting therapy and during the course of treatment should symptoms arise.

Ophthalmic Effects

Prolonged use of corticotropin may produce posterior subcapsular cataracts and glaucoma with possible damage to the optic nerves.

Infections

Corticotropin may mask some signs of infection, and new infections including those of the eye due to fungi or viruses may appear during its use. There may be decreased resistance and inability to localize infection when corticotropin is used.

Elevated Blood Pressure, Salt and Water Retention, and Hypokalemia

Corticotropin can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. Dietary salt restriction and potassium supplementation may be necessary. Corticotropin increases calcium excretion.

Vaccination

While on corticotropin therapy, patients should not be vaccinated against smallpox. Other immunization procedures should be undertaken with caution in patients who are receiving corticotropin, especially when high doses are administered because of the possible hazards of neurological complications and lack of antibody response.

PRECAUTIONS

General

Patients with latent tuberculosis or tuberculin reactivity who receive corticotropin should be closely observed as reactivation of the disease may occur. During prolonged corticotropin therapy, these patients should receive chemoprophylaxis.

Skin testing should be performed prior to treatment of all patients with suspected sensitivity to porcine protein. Immediately following intramuscular or subcutaneous administration of corticotropin all patients should be observed carefully for sensitivity reactions.

Relative adrenocortical insufficiency induced by prolonged corticotropin therapy may be minimized by gradual reduction of corticotropin dosage. This type of insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress during that period, hormone therapy should be reinstituted.

There is an enhanced effect of corticotropin in patients with hypothyroidism and in those with cirrhosis.

The lowest possible dosage of corticotropin should be used to control the condition under treatment, and when reduction in dosage is possible the reduction should be gradual.

Corticotropin should be administered for treatment only when the disease is intractable to more conventional therapy. Corticotropin should be adjunctive and not the sole therapy in the treatment of a disease.

Since maximal corticotropin stimulation of the adrenals may be limited during the first few days of treatment, other drugs should be administered when an immediate therapeutic effect is desirable.

When infection is present appropriate anti-infective therapy should be administered during corticotropin and following discontinuation of corticotropin therapy.

Treatment of acute gouty arthritis should be limited to a few days. Since rebound attacks may occur when corticotropin is discontinued, conventional concomitant therapy should be administered during corticotropin treatment, and for several days after it is stopped.

Psychic derangements may appear when corticotropin is used, ranging from euphoria, insomnia, mood swings, personality changes, and depression, to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticotropin.

Corticotropin should be used with caution in patients with diabetes, abscess, pyogenic infections, diverticulitis, renal insufficiency, and myasthenia gravis.

Growth and development of infants and children on prolonged corticotropin therapy should be carefully observed.

Although controlled clinical trials have shown ACTH to be effective in speeding the resolution of acute exacerbations of multiple sclerosis, they do not show that it affects the ultimate outcome or natural history of the disease.

Since complications of treatment with ACTH are dependent on the size of the dose and the duration of treatment, a risk/benefit decision must be made in each individual case as to dose and duration of treatment.

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